ZYNYZ J Code: J9345

Drug & Product Overview

HCPCS Descriptor Injection, retifanlimab-dlwr, 1 mg

HCPCS Added Date October 1, 2023

Manufacturer Incyte

Route of Administration Intravenous

Generic Status Single-Source; Branded

Dosage Type Single-Dose

Dosage Form Injection

About ZYNYZ

Zynyz is a medication aligned to the HCPCS J Code: J9345 for billing, pricing, and reimbursement purposes in the United States. This Oncology medication is administered via the intravenous route and manufactured by Incyte.

According to CMS Drug Use Information: Retifanlimab is used to treat certain types of cancer (such as Merkel cell carcinoma-MCC, squamous cell carcinoma). It works by changing the action of your own immune system, directing it to attack cancer cells. Retifanlimab belongs to a class of drugs known as monoclonal antibodies.

Disclaimer: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional.

NDC Code Information

Based on publicly available CMS files. The list of NDCs below is not exhaustive.

NDC Code	Drug	Manufacturer	Billing Units / Pkg	Package Size
50881-0006-03	Zynyz	Incyte Corporation	500	500 MG / 20 ML

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ZYNYZ Pricing & Reimbursement

J9345 Private Payer Reimbursement

$31.56 / HCPCS unit as of Jan 2026

National median reimbursement across major commercial payers.

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Historical Graphing and Billing Calculator

per HCPCS unit

As of Q4 2026

ZYNYZ Claims Performance

Claims from Jan 2026 – Aug 2026

Claim Denial Rate 15.1%

Avg. Days to File 7.3days

Avg. Days to Pay 23.0days

Real-world claims performance from FocalPoint, OnPoint Oncology's reimbursement analytics platform, with claims data accrued at the clearing house level.

Explore J9345 claims analytics on FocalPoint →

ZYNYZ CPT Administration Codes

CPT Code	Description
96413	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
96415	Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to code for primary procedure)

JW / JZ modifiers apply

CMS has identified Zynyz (J9345) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. Wastage billing guide →

ZYNYZ Medically Unlikely Edits (MUE)

The most billing units of J9345 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 1 mg.

Practitioner Office & Hospital Outpatient

500 units / day

= 500 mg per day

MAI 3 · Date of Service Edit: Clinical. Per-day limit based on clinical expectations; excess units are denied but may be appealed with documentation of medical necessity. See all MUE limits →

ZYNYZ Clinical Information

Indications and drug classification.

Treated Diseases & Conditions

This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.

Merkel Cell Carcinoma Squamous Cell Carcinoma of the Anal Canal

Drug Class

Programmed Death Receptor-1 Blocking Antibody [EPC]Programmed Death Receptor-1-directed Antibody Interactions [MoA]

Frequently Asked Questions

Is there an available Zynyz billing and coding guide?

Billing and coding information for ZYNYZ can be found through INCYTE CORPORATION. Visit Here →

Are there any available Zynyz patient assistance programs?

ZYNYZ patient assistance information can be found through INCYTE CORPORATION. Visit Here →

Where can I find Zynyz prescribing information?

ZYNYZ prescribing information can be found at the link below: Visit Here →

Where can I find Zynyz side effect information?

Information regarding ZYNYZ's side effects can be found at MedlinePlus Visit Here →

Does billing ZYNYZ require JZ/JW wastage modifiers?

CMS has identified ZYNYZ(J9345) as a HCPCS code with single-dose containers. Therefore, the JW/JZ wastage modifiers could be required for billing purposes. See CMS guidelines on use of the JZ and JW wastage modifiers below.

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